This is a multi-center, non-randomized, single-arm, prospective trial to evaluate a staged sampling methodology designed to maximize the diagnostic yield of lung biopsy in a single procedure setting.
The objectives of this study are to evaluate diagnostic yield following biopsy of peripheral pulmonary nodules as identified on chest computed tomography (CT) utilizing (1) Electromagnetic navigation (EMN) bronchoscopy, and/or (2) EMN-transthoracic needle aspiration (TTNA). Overall diagnostic yield will be evaluated to assess the combination of these approaches.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
150
Electromagnetic navigation bronchoscopy and electromagnetic navigation transthoracic needle aspiration
Banner University Medical Center - Phoenix
Phoenix, Arizona, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Diagnostic Yield
Diagnostic yield associated with either EMN-bronchoscopy or EMN-TTNA
Time frame: Up to one year post index procedure
Serious Adverse Events
All device and/or procedure related serious adverse events
Time frame: 30 days post index procedure
Adverse Events
Rate of all device and procedure related events
Time frame: 30 days post index procedure
Rate of procedure cancellation
Impact of same day CT scan on rate of procedure cancellations due decrease in nodule size
Time frame: On procedure day
Procedural Factors
Number of instrument passes, type of instrument, site of biopsy
Time frame: Intra-procedure
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